FDA-Device2018-12-12Class II
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Philips Medical Systems (Cleveland) Inc
Hazard
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Sold states
US Nationwide Distribution
Affected count
6,343 units in total
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0548-2019Don't want to check this manually?
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